Human beings from the four thousand years ago Babylon first case of surgery, has taken measures to prevent infection. However, the late 19th century European statistical data also show that, due to postoperative infection leading to direct deaths accounted for 60% of cases.
According to the US Centers for Disease Control and Prevention (CDC), about two million people are affected by iatrogenic infection in the nation's acute care facilities, and about $ 4.5 billion is spent annually on these patients. Today, people pay a huge price, gradually understand the truth - should eliminate all possible channels of infection, reduce the chances of infection. The study also showed that "one third of iatrogenic infections can be prevented by infection control procedures in the organization."
In fact, the hospital is to give patients in terms of health and regain life, "White Holy Land", when the patient into the hospital from the moment, will be entrusted with the health and life to the hospital, and hospital equipment used clinics, dressings and the environment , Should be shared by all relevant sectors of the responsibility, so to eliminate all possible infections and reduce the possibility of infection, but also by the various related businesses, including raw material production, preformed packaging production equipment components, and end-use sector , Together constitute a complete, safe and effective products, in the medical security alert system links to promote sterile medical device industry forward.
"There is not a single package that meets the sterility requirements, and no matter how good the product is."
(A) Overview of medical packaging:
The scope of medical packaging, including "medicinal" and "equipment", these two categories of packaging in the regulation and in the application has been strictly different. There are also packaging equipment "to be sterilized" and "do not need sterilization," the distinction, in the management and application of classification to be differentiated.
In the sterilization of the packaging of the two products in the concept of operation - "factory sterilized packaging" and "hospital sterile packaging." as the picture shows:
Medical packaging from the concept of classification, to promote the sustainable development of packaging materials and research, as well as the integrity of sterilization packaging, security, use, normative can play a fundamental role; to avoid the use of The lack of sterile properties of the appropriate packaging material can be constructive for standard manufacturing and for the use of standards.
(B) the compatibility of materials and sterilization
The importance of packaging design for medical devices is described in the introduction to ISO 11607-1; 2006: "The process of designing and developing packaging for the final sterilization of medical devices is a complex and difficult task." And the complexity of the packaging design described as: "The ultimate goal of medical equipment packaging materials can be adapted to sterilization, sterilization can protect the product, use should be kept sterile."
This statement, in line with the requirements of the sterile packaging machinery manufacturers must be the choice, to adapt to the concept of sterilization technology is the highest medical products protection. Otherwise the packaging of the product may become a deadly weapon.
The current sterilization methods are basically the use of gas ethylene oxide and formalin, high temperature steam wet and dry off, irradiation of gamma rays, and low temperature plasma sterilization. The product itself is suitable for sterilization and use of the validity period, and the adaptation of sterilization methods are selective, such as biological products can not be high temperature, PP plastic to avoid radiation, liquid products can not penetrate the gas, plasma low temperature sterilization Can not use plant fiber, all kinds of ... ... These are required in the design of packaging at the same time, first determine the sterilization methods, and sterilization methods have to adapt to the material as a basis, taking into account the preservation requirements, combined with production and processing technology to To achieve the desired effect of sterilization and sterile preservation and barrier protection purposes.
ISO11607-1: 2006 The choice of suitable materials for the final medical device packaging system is affected by the interrelationship shown below.
The interrelationships affecting the choice of packaging material for the final sterilized medical device
(C) the production process and application of glue
To ensure that the requirement for aseptic opening is stripping no fiber loss, in order to address this requirement, initially involved in the coating, the main raw material is hot-melt glue, when the hot melt adhesive coated paper on the impact of air permeability , So use the grid coating process and solve the ventilation requirements. Mesh hot melt adhesive coating due to the separation of non-paper, the processing temperature and the pressure and the combination of bonding materials with the tolerance of choice, give full play to its advantages, open medical packaging requirements: Have to open, no fiber ", has an extremely far-reaching impact. As the sterilization packaging requirements continue to increase, they showed a lack of hot-melt adhesive coating, its performance:
1. Hot melt temperature is sensitive to ethylene oxide sterilization in the temperature state, may be due to temperature and reduce the strength of the skin and broke the package resulting in sterilization failure.
2. Transport or storage, due to temperature may cause a change in the strength of hot, resulting in broken package so that sterilization failure.
3. Due to temperature and some of the contents of the product will have adhesion phenomenon.
4. Hot melt adhesive coating process, the use of non-alcohol solvent and reduce the safety factor.
5. With the sterilization of gas into and out several times at the same time, do not rule out the possibility of residual collagen into the bag.
6. Hot-melt adhesive packaging is not suitable for high-temperature sterilization.
The process of hot-melt adhesive coating opens a path for the removal of paper dust from the aseptic package. With the increasing demand for sterile packaging, these shortcomings are constantly being compensated and improved in the application. Bonding process to the emergence of the maximum to make up for the hot-melt coating process due to the lack of effective guarantee and solve the ventilation, residue, broken packets and adhesion problems. However, due to processing technology and cost of the reason that box-coating process limited to large quantities of production conditions, can not be fully promoted, or can not meet more products.
The water-soluble coating then exposes the head. Water-based adhesive solvent is alcohol or water, non-toxic, and not because of the temperature and reduce the peel strength of hot, showing more secure products to make up for the lack of hot-melt adhesive coating, the current use of water-soluble plastic raw materials, After the coating is cured, the crystalline state does not significantly impede the breathability and can also be border coating, has been gradually adopted by the manufacturer and the user acceptance of water-soluble coating process is very tolerant of the gravure, Toppan, Spray and anilox roller direct coating process. The above two kinds of coating technology, has a relatively rational and leading the status of sterilization packaging.
At present, no direct adhesive bonding can be achieved to achieve the separation of non-paper paper paper intervention further beyond the performance of the above-mentioned coating process, according to the statement, the coating process should be stripped of paper dust requirements arising, Glue can be directly applied to medical paper for the paste to omit the coating process, reduce production costs and ensure product safety, sterilization packaging materials in the choice to provide a wider range of space. Direct heat of the medical paper for the domestic medical device manufacturers to participate in quality competition and price competition for sterilization packaging out of the country, and the world, to enhance the level of domestic sterilization packaging laid a good foundation, and the actual use of And constantly improve and perfect in the common efforts of all parties to create a more perfect and more secure the world of packaging materials.
(D) to ensure that sterile design
Safety is the theme in nearly-demanding design concepts, effective sterilization is established, successful post-sterilization protection and safe use are supported by the concept of ensuring sterile design.
1. Corner fixed block, to prevent intrusion before opening the dust. Conforms to (EN868-5 / 4.3.3 Note)
2. The sterilization process indicates the size of the label. Reference (EN868-5 / 4.4)
3. Hot stitch, is to build the process of sterilization to strengthen the strength of hot stitch to prevent rupture and effective multi-channel defense. Compliance with (EN868 / 4.3.2)
4. Transparent colored plastic, so that the hot seam color becomes darker, easy to check the visual effects and visual products. Reference (EN868 / 5.1)
5. Printing site control, breathable parts of the printing as much as possible to reduce. Reference (EN868-5 / 220.127.116.11)
6. Direct contact with the product is not printed parts, can reduce and reduce the residual ink harm. Refer to (EN868-5 / 18.104.22.168)
7. Sealing fold position of the indentation to accurately seal a good bit, to avoid dislocation caused by sterilization failure. Refer to (EN868-5 / 4.3.4. Note)
8. Safety of raw material control:
A. Plastic composite solvent and glue selection; refer to (EN868-5 / 22.214.171.124)
B. No pinhole detection on the surface; refer to (EN868-5 / 126.96.36.199)
C. Plastic film without impurity test; refer to (EN868-5 / 188.8.131.52)
D. Description of the specification; see (EN868-5 / 184.108.40.206)
E. Determination of the strength of plastic films; see (EN868-5 / 220.127.116.11)
F. Paper, non-fluorescent; refer to (EN868-3 / 4.4.8)
G. Water repellency; see (EN868-3 / 4.4.13)
H. Permeability; see (EN868-3 / 4.4.10)
I. Direction of stripping; see (EN868-5, Appendix E)
J. Selection of inks, adhesives and solvents is based on non-toxic and low-toxicity raw materials. Refer to ISO 11607-1: 2006 / 5.1.7g.
(E) user-friendly design of the use of convenience.
A complete package to meet the requirements, which also contains the requirements to facilitate the use of the design of packaging, it should also design the appropriate elements in order to reflect the integrity of the packaging.
9. Double-layer material deliberately dislocation of the upper and lower films. Refer to (EN868-5 / 4.3.4.b)
10. Semicircular thumb incision, the top of the opening with the hot seam to maintain the distance requirements, designed to facilitate the tear. Refer to (EN868-5 / 4.3.4.a)
11. Opening direction indicator. Reference (EN868-4.5.5) at least also shows:
A. Open position;
B. The tearing direction at the time of peeling;
C. Direction of product loading and unloading;
12. Sterilization process instructions logo or text printed on a transparent plastic surface, because when you see the product, but also to see all the signs, from the use of a flip to see the procedures. Compliance with (ISO 11607-1: 2006 / 6.2.3.a)
13. Fill out the text location of the sterilization date, is deliberately set the direction for the use of direct view, to avoid U-turn access. Compliance with (ISO 11607-1: 2006 / 6.2.3.a)
14. Marked printing and packaging breakage prohibited. Refer to (EN868-5 / 18.104.22.168.a)
15. LOT production batch number printed to facilitate the historical traceability. Refer to (EN868-5 / 4.6.2.b)
16. Trademarks. Reference (EN868-5 / 4.6.2.c)
17. The sterilization process indicates the text that identifies the color conversion. Refer to (EN868-5 / 4.6.2.d)
18. Specifications and Dimensions. Refer to (EN868-5 / 4.6.2.f)
(6) reference to the implementation of detection methods
Medical packaging integrity of the building, a very important part of the evaluation of product safety, testing is a means of assessing security, quantification is the basis for testing, and a unified basis for implementation.
1. Tear peel strength test
According to EN868-5 Annex D literature
Objective: to ensure that before and after sterilization to the final use before the hot seam is not broken.
METHODS: At 5 points, the (15 ± 0.1) mm strip sample was cut at right angle. (Figure 1)
Conditions: Separation was carried out at a constant speed of (200 ± 10) mm / min.
Record: Test record the highest value.
Report: The strength of each 15 mm wide test specimen peeled off.
Requirements: hot-peeled part of the test without resistance (illustrated in Figure 1)
2. Sterilization process adaptability test
According to EN868-5 Annex A literature
OBJECTIVE: To determine the resistance of the sterilization process to ensure the adaptability of the sterilization process.
Methods: Take 10 units of pouch, put absorbent gauze, not squeeze.
Step: Seal the test sample according to the heat sealer used in the production.
Condition: The test sample was placed in a sterilization tester to simulate the conditions of the sterilized condition.
Procedure: Perform an action loop.
Report: Record the number of fractures in the test sample and the number of plastic splits separated or opaque.
3. Penetration testing of plastic film pinholes
According to EN868-5 Annex B literature
Objective: To determine the plastic film without pinhole, to ensure sterilization and safety.
Methods: 110 × 75 × 32mm cellulosic sponge was adhered to 110 × 75 × 12mm steel plate,
800 ± 50 g weight of the compact.
Procedure: Place the absorbent paper on the flat glass and cover it with a plastic film larger than the compact.
Conditions: Sponge briquettes inhaled for one minute of staining solution were allowed to stand for 2 minutes on the test sample, and the sponge briquettes were removed to check whether the absorbent paper was dyed.
Procedure: Repeat the rest of the test sample.
Report: Number of contaminated samples of absorbent paper.
4. Determine the fiber orientation detection method for the paper
According to EN868-5 Annex E literature
Purpose: Check the tearing direction of the heat-sealed paper.
Methods: The direction of the tear paper sealing eyes, cut two tapes, each 125mm long stick on paper, leaving 10mm at each end of non-adhesive, to ensure that the other parts of the adhesive tape intact, with the scroll in each direction 5 times, clamp the unadhesive end slowly and firmly and peel the tape in the direction of about 45 degrees, and peel the other tape in the opposite direction. Check the surface of the paper and the tape, and visually check which direction of the tension is causing the paper to matte.
Report: the direction of raising the paper.
In the above report, we try to give description and introduction, with the accumulation of a little knowledge and learning experience, and the common topic of discussion is based on our understanding of sterilization packaging, because we started late, weak foundation, The purpose is to move forward together. In fact, whether the United States, the European Union or Japan and other developed countries, the packaging of medical devices have a strict management and requirements.
The State Food and Drug Administration in order to improve the quality of domestic medical equipment, has been proposed for the implementation of medical device manufacturing GMP management plan, which is bound to put forward higher medical packaging requirements to protect the medical device manufacturers improve product quality, Accelerate the process of China's medical device manufacturers into the international market competition.